NCT00834782

Brief Summary

To compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in eyes after Penetrating Keratoplasty (KPL)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

February 2, 2009

Last Update Submit

September 13, 2009

Conditions

Corneal Transplantation

Keywords

PKIOP

Outcome Measures

Primary Outcomes (1)

  • Intra ocular pressure

    1 year

Secondary Outcomes (1)

  • Corneal compensated intra ocular pressure, Corneal hysteresis, Corneal resistance factor

    1 year

Study Arms (1)

IOP

Measuring IOP

Procedure: IOP measurement

Interventions

IOP measurementPROCEDURE

Measuring IOP

IOP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients post keratoplasty surgery

You may qualify if:

  • Eyes after KPL surgery at the Goldschleger Eye Institute in the last 10 years.

You may not qualify if:

  • Uncooperative subjects for whom good quality results are unattainable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Goldschleger eye institute, Sheba medical center

Ramat Gan, Israel

NOT YET RECRUITING

The Goldschleger eye institute, Sheba Medical Center, Tel Aviv University

Ramat Gan, Israel

RECRUITING

Related Publications (9)

  • Congdon NG, Broman AT, Bandeen-Roche K, Grover D, Quigley HA. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol. 2006 May;141(5):868-75. doi: 10.1016/j.ajo.2005.12.007. Epub 2006 Mar 9.

    PMID: 16527231BACKGROUND

  • Jain AK, Saini JS, Gupta R. Tonometry in normal and scarred corneas, and in postkeratoplasty eyes: a comparative study of the Goldmann, the ProTon and the Schiotz tonometers. Indian J Ophthalmol. 2000 Mar;48(1):25-32.

    PMID: 11271930BACKGROUND

  • Kerautret J, Colin J, Touboul D, Roberts C. Biomechanical characteristics of the ectatic cornea. J Cataract Refract Surg. 2008 Mar;34(3):510-3. doi: 10.1016/j.jcrs.2007.11.018.

    PMID: 18299080BACKGROUND

  • Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. doi: 10.1016/j.jcrs.2004.10.044.

    PMID: 15721708BACKGROUND

  • Medeiros FA, Weinreb RN. Evaluation of the influence of corneal biomechanical properties on intraocular pressure measurements using the ocular response analyzer. J Glaucoma. 2006 Oct;15(5):364-70. doi: 10.1097/01.ijg.0000212268.42606.97.

    PMID: 16988597BACKGROUND

  • Mollan SP, Wolffsohn JS, Nessim M, Laiquzzaman M, Sivakumar S, Hartley S, Shah S. Accuracy of Goldmann, ocular response analyser, Pascal and TonoPen XL tonometry in keratoconic and normal eyes. Br J Ophthalmol. 2008 Dec;92(12):1661-5. doi: 10.1136/bjo.2007.136473. Epub 2008 Aug 29.

    PMID: 18757471BACKGROUND

  • Pandav SS, Sharma A, Gupta A, Sharma SK, Gupta A, Patnaik B. Reliability of proton and goldmann applanation tonometers in normal and postkeratoplasty eyes. Ophthalmology. 2002 May;109(5):979-84. doi: 10.1016/s0161-6420(02)00974-0.

    PMID: 11986107BACKGROUND

  • Rao VJ, Gnanaraj L, Mitchell KW, Figueiredo FC. Clinical comparison of ocular blood flow tonometer, Tonopen, and Goldmann applanation tonometer for measuring intraocular pressure in postkeratoplasty eyes. Cornea. 2001 Nov;20(8):834-8. doi: 10.1097/00003226-200111000-00011.

    PMID: 11685061BACKGROUND

  • Touboul D, Roberts C, Kerautret J, Garra C, Maurice-Tison S, Saubusse E, Colin J. Correlations between corneal hysteresis, intraocular pressure, and corneal central pachymetry. J Cataract Refract Surg. 2008 Apr;34(4):616-22. doi: 10.1016/j.jcrs.2007.11.051.

    PMID: 18361984BACKGROUND

Study Officials

  • Shlomo Melamed, Prof

    Sheba medical center, head of Sam rotberg glaucoma center

    STUDY CHAIR

Central Study Contacts

Ido Didi Fabian, Dr

CONTACT

+9727830444didifabian@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

IL(2)